Both start-ups and big companies are moving into the liquid biopsy market today, but now Birmingham, Alabama-based Circulogene Theranostics has entered the arena with its promise of tools that use small blood samples to screen for tumour DNA!

The company has announced the commercial launch of its cell-free DNA (cfDNA) liquid biopsy products for the fast, accurate and personalised testing of ten tumour types, including breast, lung and colon cancer, making it the first and only biotechnology company able to enrich circulating cfDNA from a single blood drop for patient-specific monitoring of cancer.

‘As soon as a patient receives a positive diagnosis of cancer from his or her physician,’ said Circulogene CEO, Mike Mullen, ‘our test provides a rapid and cost effective tool to aid the physician in planning, implementing and monitoring the treatment process. Research has shown cancers change rapidly and shed tumour DNA into circulating blood. Our technology detects and monitors tumour changes in a very specific and sensitive way. This allows us to report to physicians in just days to aid them in selecting the right therapy for the right patient at the right time.’

The result is potentially the most precise, rapid and cost-effective monitoring and targeted treatment of cancer possible. Newly-published clinical research demonstrates the company’s proprietary method can collect more than 100 times more cfDNA with just 1/10 of the blood (as little as 20 microliters) compared to the current industry standard for non-invasive liquid biopsy testing. Circulogene’s proprietary technology is capable of detecting nearly 3000 cancer mutations on 50 well-established cancer-associated genes for its ten cancer profiles.

In addition to providing the most accurate, actionable information, the company’s proprietary cfDNA enrichment method delivers highly cost-effective genetic results from a single drop of various body fluids, including blood, in as little as seven days instead of weeks or months. With this major technological advance, Mullen shares the industry’s belief that tumor genome sequencing of circulating cfDNA to manage cancer treatment can potentially become an important component of the standard of care.

‘We’ve assembled a highly experienced and credentialed diagnostic team around a much-needed technology,’ continued Mullen. ‘Similar to how diabetics monitor glucose levels, our test can accurately identify established genetic tumour mutations, drug resistance and remission in diagnosed cancer patients using a simple finger stick and drops of blood. This allows oncologists to use current FDA-approved and NCCN/ASCO-endorsed treatment options to respond to these changes at a fraction of the cost of standard liquid biopsy testing.’